Houston partner Scott McBride authored an article for the July 16 edition of Texas Lawyer titled, "Lax Oversight of Transplant Centers Prompts Government Action."
The article focuses on the new rules, which went into effect June 28, governing organ transplant centers in hospitals across the United States. "The Centers for Medicare & Medicaid Services (CMS) had set forth various requirements applicable to transplant centers, but CMS did not closely monitor the centers after the initial certification," according to McBride. "Lawyers who represent transplant centers or hospitals that house them need to know about these new requirements," he stated.
McBride details some of the key circumstances which led to the new rules being placed into effect, including transplant programs not "performing an adequate number of transplants to maintain appropriate experience and proficiency," or not having appropriate transplant surgeons to perform the transplant surgeries.
According to McBride, the CMS "published a final rule that establishes centralized Medicare Conditions of Participation for transplant centers," which pertain to such issues as "data submission, clinical experience and outcomes, patient and living donor selection and management, organ recovery and receipt, quality assessment and performance improvement, human resources, organ procurement, and patient and living-donor rights," and "require a reapproval process every three years."
McBride concludes: "Organ transplant centers may not agree with all the requirements in the new rules. However, all hospitals should agree that the increased oversight is a better mechanism to ensure patient safety and build patient confidence in the organ transplant process."